精品一久久_日韩成人激情_av2016天堂网_国产成年片_日日影视_精品国产观看

1. Compliance Ensure compliance with the applicable pharmacovigilance SOPs Ensure and monitor pharmacovigilance compliance with local regulations. Notify regional RPP regarding any new or updated national pharmacovigilance requirements for the countries of responsibility. Ensure that any communication from local regulatory authority related to Pharmacovigilance is communicated to Regional RPP and is promptly and adequately addressed. 2. Adverse drug reaction management Follow-up local ADR cases for further clarification with the reporter and HCPs and completeness. Forward ADR information collected to the Regional Pharmacovigilance office. 3. Pharmacovigilance reports management Report processed ADRs to the local regulatory authorities, as applicable, in accordance with local regulations and maintain a submission log. Ensure timely submission of the periodic safety reports received, as applicable, to local regulatory authorities and maintain a submission log. Comply with the timelines specified in this regard in the applicable pharmacovigilance SOPs and regulations. 4. SDEA management for China 5. Others arranged by team leader Fresh graduate or 1 year experience Major in Science or Pharmacy Good English 1.遵守 確保符合適用的藥物警戒SOP 確保并監督藥物警戒符合當地法規。 就責任國的任何新的或更新的國家藥物警戒要求通知區域RPP。 確保與藥物警戒相關的當地監管機構的任何通信均傳達給區域RPP，并及時、充分地處理。 2.藥物不良反應管理 跟進當地ADR案例，與報告人和醫務人員進一步澄清，并確保完整性。 將收集的ADR信息轉發給區域藥物警戒辦公室。 3.藥物警戒報告管理 根據當地法規向當地監管機構報告處理后的ADR（如適用），并保存提交日志。 確保及時向當地監管機構提交收到的定期安全報告（如適用），并維護提交日志。 遵守適用的藥物警戒SOP和法規中在這方面規定的時間表。 4.SDEA中國管理 5.其他等